Cefaly® 10230

GUDID 05425018850129

The Cefaly® Prevent device is indicated for the prophylactic treatment of episodic migraine in adults.

Cefaly Technology SPRL

Craniofacial analgesia electrical stimulator

• Primary Device ID: 05425018850129
• NIH Device Record Key: c64df6ad-231d-4f35-a861-483e1ea48e8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cefaly®
• Version Model Number: Prevent
• Catalog Number: 10230
• Company DUNS: 762450752
• Company Name: Cefaly Technology SPRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (203) 309-5670
• Email: info@cefaly.us
• Phone: (203) 309-5670
• Email: info@cefaly.us

Operating and Storage Conditions

• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	05425018850129 [Previous]
GS1	05425018850266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160237

FDA Product Code

• PCC: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-11
• Device Publish Date: 2017-11-29

On-Brand Devices [Cefaly®]

• 05425018850129: The Cefaly® Prevent device is indicated for the prophylactic treatment of episodic migraine in
• 05425018850259: The Cefaly® Dual device is indicated for: - The acute treatment of migraine with or without aur
• 05425018850242: The Cefaly® Acute device is indicated for the acute treatment of migraine with or without aura
• 05425018850150: Kit 3 Electrodes Blue Gel for Cefaly II
• 05425018850143: Kit 3 electrodes for Cefaly II
• 05425018850105: Kit 3 electrodes Blue Gel for Cefaly I
• 05425018850044: Kit 3 electrodes for Cefaly I
• 05425018850273: Cefaly DUAL Enhanced is a newer version of Cefaly DUAL which is an FDA - cleared device Indicat
• 05425018850181: Hypoallergenic Electrode CEFALY Enhanced Kit (3 electrodes)
• 05425018850174: CEFALY Enhanced Electrode Kit .3 electrodes